Coated VICRYL VCP214H (UDI 10705031051669)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031051669), received between Dec 31, 2024 and Jan 12, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT, HAD TWO NEEDLES BREAK OFF OF THE STRING THIS MORNING AND ONE WAS IN THE PATIENT SUBCUTANEOUS, AND THEY HAD TO RETRIEVE IT. NO INJURIES OR ADVERSE EVENT IS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037066 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT, HAD TWO NEEDLES BREAK OFF OF THE STRING THIS MORNING AND ONE WAS IN THE PATIENT SUBCUTANEOUS, AND THEY HAD TO RETRIEVE IT. NO INJURIES OR ADVERSE EVENT IS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036784 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE AND LIGATURE WERE NOT CONNECTED, THEY WOULD FALL APART QUICKLY. NO ADVERSE IMPACT PATIENT/USER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888711 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE AND LIGATURE WERE NOT CONNECTED, THEY WOULD FALL APART QUICKLY. NO ADVERSE IMPACT PATIENT/USER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888708 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SENDER THAT WE HAVE HAD AN ISSUE WITH ONE OF YOUR PRODUCTS. VICRYL PLUS VCP214, LOT TCMCAR, EXP FEB 2028. OUR VETERINARIANS HAVE HAD MANY SUTURE PACKS FROM THIS LATEST BOX THAT THE NEEDLE HAS BROKEN DURING PROCEDURES, WHICH NORMALLY DOESN'T HAPPEN AT ALL? NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047854 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD AN ISSUE WITH ONE OF THE PRODUCTS. THEIR VETERINARIANS HAVE HAD MANY SUTURE PACKS FROM THIS LATEST BOX THAT THE NEEDLE HAS BROKEN DURING PROCEDURES, WHICH NORMALLY DOESN'T HAPPEN AT ALL. UNKNOWN IF THE DEVICE WAS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047852 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and